CO-CODAMOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL ; CODEINE PHOSPHATE HEMIHYDRATE

Available from:

Mercury Pharmaceuticals Ltd

ATC code:

N02AJ06

INN (International Name):

PARACETAMOL ; CODEINE PHOSPHATE HEMIHYDRATE

Dosage:

30/500 Milligram

Pharmaceutical form:

Tablets Effervescent

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

codeine and paracetamol

Authorization status:

Not marketed

Authorization date:

2010-10-08

Patient Information leaflet

PROOF
1
11/07/2014
Product Description:
Originated by
Date:
Tech Approved
Date:
Co-codamol 30mg/500mg Effervescent Tablets
SJT
28/03/2012 No
Component:
Revised by
Version:
Leaflet
PAT
101777/LF/4
Manufacturer:
File Name:
CRF No.:
Unither Industries
101777LF Co-codamol 30mg500mg TabsUK v4_1
AMCo.CRF.269.2014
Market:
Software Package:
Barcode:
UK/ROI
Quark Xpress 9
N/A
Minimum Font Size & Typeface:
Dimensions:
Pharma Code:
8.5pt Swiss 721BT
210 x 250mm
N/A
COLOURS:
KEY LINE:
Black
Date of Approval:
N/A
To be implemented by:
N/A
Magenta
P4
P1
LAETUS
NO.
LAETUS
NO.
LAETUS
NO.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. You can also
report side effects
directly (see details below)
United Kingdom
The Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
or
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: [phone];
Fax: [phone];
Website: www.hpra.ie;
e-mail: [e-mail].
By reporting side effects you can help provide more information on the
safety of
this medicine.
5. HOW TO STORE CO-CODAMOL EFFERVESCENT TABLETS
• Keep this medicine out of the sight and reach of children.
• Do not use Co-codamol Effervescent Tablets after the expiry date
which is
stated on the carton and the blister. The expiry date refers to the
last day of
that month.
• Do n ot store above 25
o
C. Keep the tubes tightly closed in order to protect
from moisture.
Medicines should not be disposed of via wastewater. Ask your
pharmacist how to
dispose of medicines no longer required. These measures will help to
protect the
environment.
6. FURTHER INFORMATION
WHAT CO-CODAMOL EFFERVESCENT TABLETS CONTAIN:
• The active substances are codeine phosphate hemihydrate 30mg and
paracetamol 500mg.
• The other ingredients are sodium hydrogen carbonate, sodium
carbonate
anhydrous, citric acid anhydrous, sodium docusate, sorbitol, saccharin
sodium, dimeticone, sodium benzoate, macrogol 6000 and spray-d

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Codamol 30mg/500mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Codeine Phosphate hemihydrate 30mg and
Paracetamol 500mg.
Excipients: Each tablet also contains 487mg of sorbitol and 413 mg of
sodium.
For a full list of excipients see 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet
Bevelled, flat, round, white tablet with a score line on one face
Although Co-Codamol tablets have a score line the tablets are not to
be halved as they do not divide into equal doses
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to severe acute pain.
Codeine is indicated for the treatment of acute moderate pain which is
not considered to be relieved by other analgesics
such as paracetamol or ibuprofen.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Oral
The tablets should be placed in a glass of water and allowed to be
dissolved completely. The resulting solution should
be drunk immediately.
Adults: The usual dose is one or two tablets every six hours as
required.
The total daily dose should not exceed 4 g
paracetamol (8 tablets in a day).
Codeine should be used at the lowest effective dose for the shortest
period of time.
This dose may be taken,
up to 4
times a day at intervals of not less than 6 hours. Maximum daily dose
should not exceed 240 mg.
The duration of treatment
should be limited to 3 days and if no effective pain relief is
achieved the patients/carers
should be advised to seek the views of a physician.
Elderly; As for adults, however a reduced dose may be required (see
section 4.4)
Paediatric population: Not recommended in children below the age of 18
years (see section 5.1).
4.3 CONTRAINDICATIONS
Hypersensitivity to either paracetamol or codeine, or any of the
excipients of Co-codamol tablets.
Conditions
where
morphine
and opioids
are
contraindicated e.g.,
acute
asthma,
respiratory depression,
acute
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